Inflammatory reaction following bovine pericardium graft augmentation for posterior vaginal wall defect repair.
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Animals↗
Biomedical subjects
G Willy Davila
Publications and source records attributed to G Willy Davila.
Clinical implications of the biology of grafts: conclusions of the 2005 IUGA Grafts Roundtable.
With few exceptions, the current expansion of graft utilization in pelvic reconstructive surgery is not a product of evidence-based medicine. Abdominal sacrocolpopexy and suburethral sling procedures are two situations under which synthetic graft utilization is indicated, based on randomized prospective trials and reported clinical outcomes. Otherwise, indications and contraindications for graft utilization are unclear. Current published data on the biology of synthetic and biologic grafts are limited and overall not very helpful to the reconstructive surgeon who is faced with the selection of a graft for use during a reconstructive procedure. This Roundtable presented the opportunity for a series of basic science researchers to present their data to a group of reconstructive surgeons and provide publishable background information on the various currently available grafts. The occurrence of healing abnormalities after graft implantation is becoming increasingly recognized as a potentially serious problem. To date, definitions and a classification system for healing abnormalities do not exist. Based on the input from basic scientists and experienced surgeons, a simple classification is suggested based on the site of healing abnormality, timing relative to graft implantation, presence of inflammatory changes, and the viscera into which the graft is exposed. Many opportunities for clinical and basic science research exist. As the use of grafts in reconstructive surgery is expanded, surgeons are encouraged to familiarize themselves with currently published data, and determine whether a graft should, or should not be, utilized during a reconstructive procedure, and if so, the type of graft best indicated in each specific clinical situation.
Animals↗
Transdermal oxybutynin for overactive bladder.
Overactive bladder is commonly treated with oral anticholinergic drugs such as oxybutynin chloride. Although oral anticholinergic agents have been effective in controlling urinary urgency and frequency and in decreasing incontinence episodes, adverse events, particularly dry mouth, often cause patients to discontinue oral therapy and to endure incontinence. Oxybutynin can be delivered transcutaneously, maintaining the efficacy of oral oxybutynin while significantly minimizing the side effects (eg, dry mouth) that may complicate therapy. By avoiding hepatic and gastrointestinal metabolism of oxybutynin, less N-desethyloxybutynin is produced (this compound is deemed responsible for the anticholinergic side effects such as dry mouth). This novel oxybutynin formulation offers patients who have overactive bladder and urge urinary incontinence a well-tolerated option for managing the symptoms of overactive bladder.
Administration, Cutaneous↗
Safety and effectiveness of Colpexin Sphere in the treatment of pelvic organ prolapse.
Our objective was to determine the safety and effectiveness of Colpexin Sphere in women with advanced genital prolapse. A total of 39 subjects were enrolled in our prospective multicenter clinical trial, and 27 completed the full 16-week assessment. At baseline, subjects were fitted with a sphere, instructed on insertion and removal, and educated on a regimen of pelvic floor muscle exercises performed with the device in place. Efficacy was evaluated by a baseline vs 16-week comparison of pelvic organ prolapse staging and pelvic floor muscle strength assessment. Safety evaluation included, but was not limited to, an assessment of vaginal mucosal integrity. Subjects also completed a patient satisfaction questionnaire at the end of the study. Improvement in the prolapse of at least one vaginal segment was seen in 81.5% of the subjects, while 63% exhibited improved muscle function on digital examination at 16 weeks. Twenty-five (92.6%) would recommend the device to treat prolapse, and most found it easy to insert (96.3%) and remove (100%). In short-term usage, problems with urination (29.6%) and defecation (72%) were reported, primarily due to device displacement. Two subjects developed superficial vaginal mucosal ulceration, which resolved spontaneously. No significant adverse events were reported.
Adult↗
Transdermal oxybutynin in the treatment of adults with overactive bladder: combined results of two randomized clinical trials.
The safety and efficacy of oxybutynin transdermal delivery system (oxybutynin-TDS) versus placebo in adults with urge and mixed urinary incontinence was investigated using combined results from double-blind stages of 2 phase 3 clinical trials. Study 1: placebo-controlled, parallel-group comparison of 3 oxybutynin-TDS doses in 12-week double-blind and open-label periods, followed by a 28-week open-label extension. Study 2 was a 12-week randomized, double-blind, placebo-controlled comparison of oxybutynin-TDS versus long-acting tolterodine and placebo, followed by a 52-week open-label extension. Efficacy analysis included 241 patients receiving oxybutynin-TDS, 244 receiving placebo. Most participants were Caucasian women (92%). Approximately 60% received prior anticholinergic therapy. Primary outcome was determined by changes from baseline to end of treatment in frequency of incontinence episodes, frequency of urination, and void volume. Oxybutynin-TDS was significantly more effective than placebo in reducing median daily incontinence episodes (-3.0 vs placebo -2.0; P=.00004) and daily urinary frequency (-2.0 vs -1.0; P=.0023), and in increasing void volume (25 mL vs 5.5 mL; P<.00001). Overall rates of anticholinergic adverse events (AEs) were 12.8% for oxybutynin-TDS and 11.0% for placebo (P=0.5421). The most common systemic anticholinergic AEs were dry mouth (7.0% for oxybutynin-TDS vs 5.3% for placebo) and constipation (2.1% vs 2.0%). Application site erythema occurred in 7.0% of participants who received oxybutynin-TDS (3.7% discontinuation rate); pruritus occurred in 16.1% (3.3% discontinuation rate). Transdermal oxybutynin was shown to be efficacious, with a proven safety profile. It may be utilized for patients with overactive bladder as a treatment option that could enhance compliance.
Administration, Cutaneous↗
Suprapubic-vaginocutaneous fistula 18 years after a bladder-neck suspension.
BACKGROUND: Several complications are associated with healing after pelvic reconstructive surgery for stress urinary incontinence. These include infection, hemorrhage, erosion, and fistula formation. CASE: A 67-year-old woman presented with simultaneously draining vaginal and suprapubic sinuses. Examination revealed a vagino-abdominal fistula. Surgical excision found an abscess around synthetic material from a previous bladder-neck suspension. CONCLUSION: Unusual fistulation can occur remotely from anti-incontinence surgery, especially when graft materials are used.
Aged↗
Bladder-health diaries: an assessment of 3-day vs 7-day entries.
OBJECTIVES: To assess the reliability of symptom reports in 3-day vs 7-day bladder diaries used in clinical trials of patients with overactive bladder (OAB) and to compare those results and related issues with previous reports. MATERIALS AND METHODS: We analysed two large-scale, randomized, phase 3 clinical trials of the use of transdermal oxybutynin for treating patients with OAB. The first trial (Trial A, 520 patients) compared three doses of transdermal oxybutynin (1.3, 2.6 and 3.9 mg/day) with placebo. Patients documented their OAB symptoms in a 7-day diary. The second clinical study (Trial B, 361 patients) compared the efficacy of 3.9 mg/day transdermal oxybutynin with 4 mg/day extended-release tolterodine and with placebo; this trial required symptom recording for only 3 days. The internal consistency of the data from the 7-day trial was determined and then compared with the 3-day trial results. RESULTS: Patients on transdermal oxybutynin or long-acting tolterodine for their OAB symptoms showed a clinically and statistically significant improvement, results that were documented in both 3-day and 7-day bladder diaries. However, compared with 7-day symptom records, 3-day diaries were associated with significantly better compliance with record-keeping (P < 0.001). CONCLUSIONS: Seven-day diaries used in clinical trials supply accurate and reproducible data on clinical manifestations of OAB, but 3-day diaries are equally effective and have the potential for better accuracy through increased patient convenience. Three-day diaries may also reduce the tendency for patients to complete gaps in record-keeping from memory.
Benzhydryl Compounds↗
Vaginal vault prolapse: identification and surgical options.
Reconstructive surgeons should be familiar with the identification and treatment of vaginal vault prolapse. Most utilized techniques can be effective in terms of suspension of the vaginal apex. New technology has allowed for the performance of vaginal-approach techniques with increasingly physiologic anatomic and functional outcomes (Figure 8).
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Optimizing pelvic surgery outcomes.
Most perioperative complications related to graft use can be prevented by appropriate preoperative and postoperative tissue management. Intraoperative cystoscopy should be a routine part of most pelvic reconstructive procedures. A rectal examination should be performed at the end of each surgical procedure to document rectal integrity. Under most circumstances, graft erosions can be managed without the need to remove the entire graft or jeopardizing the surgical repair.
Aging↗
Air-charged and microtransducer urodynamic catheters in the evaluation of urethral function.
This study aimed to compare measurements of urethral pressure profile and Valsalva leak point pressure (VLPP) obtained with air-charged and microtransducer catheters. Forty-five women with urogynecologic dysfunction underwent multichannel urodynamic evaluation including maximum urethral closure pressure (MUCP), functional urethral length (FUL), and VLPP with air-charged balloon catheters as well as microtransducer catheters. Lin's concordance coefficient was used to examine the agreement of MUCP, VLPP, and FUL measurements with the two catheters. The MUCPs measured with the two catheters had a high concordance coefficient of 0.69 (95% CI 0.50, 0.82). The VLPP measurements obtained with the catheters also agreed well, with a concordance coefficient of 0.71 (95% CI 0.43, 0.87). The measurements of mean FUL had a low concordance of 0.35 (95% CI 0.085, 0.57). Overall, air-charged and microtransducer catheters yield similar information when evaluating VLPP and MUCP. There were differences in FUL and these were likely due to different catheter diameters.
Aged↗
Initial experience with a new method for the dynamic assessment of pelvic floor function in women: the Kolpexin Pull Test.
The aim of this study was to evaluate a newly developed, simple test for assessing pelvic floor muscular function in women. Pelvic floor strength in women with symptomatic pelvic floor dysfunction was evaluated with a newly developed assessment tool, the Kolpexin Pull Test, and compared to a clinically validated digital pelvic floor strength assessment scale (DPA). A 36-mm Kolpexin sphere was inserted into the vagina above the levator plate and connected to a digital tensiometer/force gauge. The force required to remove the sphere was recorded for three resting trials and three maximum pelvic floor contractions. Results of the DPA and Kolpexin Pull Test were analyzed using ANOVAs of contrast variables, intraclass correlations, and regression analyses. Twenty-one women participated in the study. Age range was 36-85 years, parity range was 2-5. All six trials required less than 5 min to perform in each patient. Intraperson maximum contraction data were correlated at 0.96 (95% CI: 0.91, 0.98), and were greater at higher DPA scores ( p=0.016). There were positive correlations between the maximum contraction and DPA data (adjusted R(2)=0.52; p <0.001), and the maximum contraction minus resting vs DPA data (adjusted R(2)=0.54; p< 0.001). The Kolpexin Pull Test is reproducible, rapid, and correlates with digital clinical assessment of pelvic floor strength during maximal contractions.
Adult↗
Prospective trial of gasless laparoscopic Burch colposuspension using conventional surgical instruments.
STUDY OBJECTIVE: To prospectively evaluate the use of gasless laparoscopy techniques in the performance of a traditional Burch colposuspension in women with urodynamically-demonstrated genuine stress incontinence and urethral hypermobility. DESIGN: Multicenter, prospective, single-intervention series (Canadian Task Force Classification II-2). SETTING: Three urogynecologic referral centers. PATIENTS: Fifty-eight women. INTERVENTION: Traditional Burch colposuspension performed utilizing gasless laparoscopic access and conventional surgical instruments. MEASUREMENTS AND MAIN RESULTS: Follow-up was 12 to 38 months. On pad testing, urine loss was significantly reduced, from 6.0 g (CI: 0.55-11.45) to 0.3 g (CI: 0-1.53). Average daily incontinence episodes based on 7-day voiding diaries decreased from 4.7 (CI: 0.87-8.53) to 0.3 (CI: 0-1.58). Q-tip angles were normalized: 49.8 degrees (CI: 40.86-58.74) to 10 degrees (CI: 1.49-18.51). Ninety-five percent of subjects reported resolution of stress incontinence. Three subjects (5%) reported recurrent/persistent genuine stress incontinence: one was operated on during the postpartum period while breastfeeding, and two developed intrinsic sphincteric deficiency postoperatively. Fifty-five percent of subjects underwent other pelvic reconstructive surgery including posterior wall repairs. Average operative time was 60.8 minutes (range, 40-92). The ideal candidate has an unscarred abdominal wall. CONCLUSION: Gasless laparoscopic access was used to effectively perform traditional Burch colposuspension using conventional open surgical instruments. Bladder neck hypermobility was normalized in all subjects, and 95% of subjects reported no further stress incontinence.
Adult↗
Pelvic floor dysfunction in morbidly obese women: pilot study.
OBJECTIVE: The objective of this study was to evaluate the impact of obesity on pelvic floor function in women. RESEARCH METHODS AND PROCEDURES: This was a prospective controlled study of 20 morbidly obese female patients planning to undergo gastric bypass surgery and 20 age-matched female controls. Subjects completed symptom and impact questionnaires, including the Incontinence Impact Questionnaire (IIQ-7), Urogenital Distress Inventory (UDI), the Kobashi Prolapse Symptom Inventory and Quality-of-Life Questionnaire (PSI-QOL), and Index of Female Sexual Function. Data were analyzed with Wilcoxon or ratio chi2 tests. RESULTS: Mean weight was 295.7 +/- 87.9 lbs in the study group and 144.79 +/- 33.07 lbs in the control group. Mean BMI was 52.65 +/-14.49 kg/m2 in the study group and 25.11 +/- 5.27 kg/m2 in the control group. According to the IIQ-7, urinary incontinence significantly affected lifestyle in the study group. The total IIQ-7 score was also significantly affected in the study group (p = 0.03). The UDI indicated more urinary leakage with activity (p = 0.04) and more incidents of small amounts of leakage (p = 0.02) in the study group. According to the PSI-QOL, women in the study group experienced constipation more often because of difficulty in emptying the rectum (p = 0.04). The PSI-QOL score was higher in the study group (6.75 +/- 6.84) than in the control group (2.65 +/- 3.03; p = 0.04). There were no significant differences between groups regarding sexual function. DISCUSSION: Morbid obesity is associated with a significant negative impact on urogenital health. Sexual function did not seem to be affected in women who are morbidly obese.
Adult↗
Urogynecological and reconstructive pelvic surgery in women aged 80 and older.
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Age Factors↗
Effect of genital prolapse on assessment of bladder neck mobility by the Q-tip test.
OBJECTIVE: To investigate the effect of vaginal prolapse and bladder fullness on Q-tip test assessment of urethral mobility. METHODS: Twenty-six women with genital prolapse to or beyond the hymen and undergoing urodynamics for urogynecologic dysfunction were assessed by the Q-tip test. Measurements were obtained with the bladder empty, with and without the prolapse reduced by the posterior blade of a Graves speculum. Angles were repeated at bladder capacity. Measured Q-tip angles were compared using the Wilcoxon signed rank test. RESULTS: Q-tip angles were significantly altered by vaginal prolapse and bladder fullness. With an empty bladder, the median Q-tip angle measured with the prolapse reduced was significantly less than that measured without reduction (53 degrees, interquartile range 25-65, versus 68 degrees, interquartile range 45-75; P <.001). With a full bladder, similar but lesser results were obtained (33 degrees, interquartile range 15-55 [reduced] versus 48 degrees, interquartile range 31-60 [unreduced]; P <.001). The median Q-tip angle with an empty bladder was greater than that with a full bladder. With the prolapse reduced, the Q-tip angle was 53 degrees (interquartile range 25-65) with an empty bladder versus 33 degrees (interquartile range 15-55) with a full bladder (P <.001). Without the prolapse reduced, the median Q-tip angle was 68 degrees (interquartile range 45-75) with an empty bladder and 48 degrees (interquartile range 31-60) with a full bladder (P <.001). CONCLUSION? Measurement of urethral mobility by the Q-tip test is significantly affected by genital prolapse. Q-tip angles are less with the reduction of vaginal prolapse and with the bladder full. Standardization of measurement technique is necessary for the development of clinical management recommendations.
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Comparative efficacy and safety of transdermal oxybutynin and oral tolterodine versus placebo in previously treated patients with urge and mixed urinary incontinence.
OBJECTIVES: To compare the efficacy and safety of an oxybutynin transdermal delivery system (OXY-TDS) and oral, long-acting tolterodine (TOL-LA) with placebo in previously treated patients with urge or mixed urinary incontinence. METHODS: After withdrawal of their current antimuscarinic therapy, 361 adult patients were randomized to 12 weeks of double-blind, double-dummy treatment with twice weekly OXY-TDS 3.9 mg/day, daily TOL-LA 4 mg, or placebo. Evaluations included change from baseline in patient urinary diary symptoms, incontinence-specific quality of life, and safety. RESULTS: OXY-TDS 3.9 mg/day and TOL-LA 4 mg/day significantly reduced the number of daily incontinence episodes (median change -3 OXY-TDS and -3 TOL-LA versus -2 placebo; P <0.05), increased the average void volume (median change 24 and 29 mL versus 5.5 mL, P <0.01), and improved quality of life (incontinence impact questionnaire [IIQ] total score, P <0.05; Urogenital Distress Inventory Irritative Symptom subscale, P <0.05) compared with placebo. The most common adverse event for OXY-TDS was localized application site pruritus (14% versus 4% placebo) accompanied by a low incidence of systemic side effects (eg, dry mouth 4.1%). Anticholinergic adverse events occurred with greatest frequency during TOL-LA treatment (dry mouth 7.3% versus 1.7% placebo, P <0.05). CONCLUSIONS: OXY-TDS and TOL-LA are effective and comparable treatments for patients with urge and mixed incontinence. OXY-TDS improves systemic safety with regard to anticholinergic side effects. Local skin irritation occurs in some OXY-TDS patients.
Administration, Cutaneous↗
Are women with urogenital atrophy symptomatic?
OBJECTIVE: The purpose of this study was to determine the degree of correlation between physical signs of genital atrophy and symptoms that are suggestive of atrophic vaginitis. STUDY DESIGN: Female volunteers (n = 135; mean age, 69 years) rated the presence and severity (rating, 0-3) of vaginal atrophy symptoms. The presence and severity of vaginal mucosal changes, which included vaginal pH (0-3), were recorded during a pelvic examination. A vaginal cytologic maturation value was performed. Symptoms, signs, pH, and maturation value were correlated by the Spearman rank test. RESULTS: Symptom scores were low (mean, 0.41; range, 0-2.6). Symptoms were only weakly correlated with physical findings (r = 0.14) and not with maturation value (r = 0.06) or age (r = -0.004). There was a moderate correlation between physical examination score and maturation value (r = -0.48). In women > or =65 years old, symptom score and physical examination score were correlated weakly (r = 0.25). Low pH correlated well with high maturation value (r = -0.52). Women who were undergoing estrogen therapy had higher symptoms scores (P =.0007) and maturation values (P =.0002) than women who were not undergoing therapy. CONCLUSION: Although urogenital atrophy occurs universally after menopause, most elderly women are minimally symptomatic. Those women on estrogen replacement therapy may be more symptomatic. Symptoms alone should not be used as a guide for the initiation of estrogen therapy.
Adult↗
Urogynecologists are not encouraging a higher cesarean section rate.
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Cesarean Section↗